EP0250904B1 - Emballage pour un applicateur de médicaments renfermant un produit non stérilisable et méthode de fabrication - Google Patents

Emballage pour un applicateur de médicaments renfermant un produit non stérilisable et méthode de fabrication Download PDF

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Publication number
EP0250904B1
EP0250904B1 EP87108011A EP87108011A EP0250904B1 EP 0250904 B1 EP0250904 B1 EP 0250904B1 EP 87108011 A EP87108011 A EP 87108011A EP 87108011 A EP87108011 A EP 87108011A EP 0250904 B1 EP0250904 B1 EP 0250904B1
Authority
EP
European Patent Office
Prior art keywords
container
solvent
carrier
active ingredient
semi
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP87108011A
Other languages
German (de)
English (en)
Other versions
EP0250904A2 (fr
EP0250904A3 (en
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ASSUNZIONE O VARIAZIONE MANDATO;MARCHI & MITTLER S
Original Assignee
Dr Ruhland Nachf GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dr Ruhland Nachf GmbH filed Critical Dr Ruhland Nachf GmbH
Priority to AT87108011T priority Critical patent/ATE74772T1/de
Publication of EP0250904A2 publication Critical patent/EP0250904A2/fr
Publication of EP0250904A3 publication Critical patent/EP0250904A3/de
Application granted granted Critical
Publication of EP0250904B1 publication Critical patent/EP0250904B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0095Packages or dispensers for prostheses or other implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/206Ethylene oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

Definitions

  • the invention relates to a package with an active substance carrier contained therein and loaded with a non-sterilizable active substance. It also relates to a method for producing such packaging.
  • the materials that can usually be implanted within the scope of surgical measures must meet the strict sterility requirements. Surgeons often remove infectious foci after removal or removal of tumors implanted with bioabsorbable drug carriers that locally achieve an antibiotic or cytostatic effect. In the case of large-scale resections, it may be necessary to use materials with hemostatic properties in combination with medicinal products, particularly on parenchymatous organs.
  • Bioresorbable drug carriers are, for example, materials of biological origin, such as fibrin, collagen, oxidized cellulose, chitin or derivatives thereof, and also synthetic polymers such as polylactic acid or polyglycolic acid. These drug carriers can usually be sterilized using standard methods, e.g. by irradiation with gamma rays, or by treatment with ethylene oxide.
  • a number of drugs, but in particular drugs with a protein character cannot be sterilized by chemical or physical methods because they are changed under the sterilization conditions, e.g. a dismantling takes place. In this case, it is necessary that the drug carrier loaded with the drug is already produced under aseptic conditions, because subsequent sterilization is no longer possible.
  • a sterilizable packaging made of a thermoplastic film which has a transparent cover film and a fiber film.
  • This fiber film enables gas, steam or radiation sterilization.
  • Remington's Pharmaceutical Sciences, 16th edition, 1980 The lyophilization of heat-labile substances and the aseptic filling of sterile-filtered solutions into sterilized containers with subsequent freeze-drying are known.
  • the materials used for the containers must adequately protect the drug carrier loaded with the active ingredient. Glass and thermostable plastics as well as plastics that are also suitable for fumigation with ethylene oxide meet these requirements.
  • the containers must be constructed in such a way that an aseptic homogeneous loading of the drug carrier with the drug is ensured. This is best done through a septum incorporated in the container.
  • the sterile-packed, drug-laden drug carrier must be removable by the surgeon while observing sterile cautery.
  • the open container is a flat, deep-drawn container made of a thermoformable plastic.
  • Such a container can easily be mass-produced by simply modifying packaging machines known per se, e.g. by thermoforming foils.
  • the shape of the container can be deep-drawn in one operation and a septum can also be provided.
  • a semipermeable membrane e.g. a coated paper
  • the septum is then glued or inserted into the device provided for this purpose (recess or saving).
  • the septum can also be incorporated into the semi-permeable membrane serving as a closure.
  • the septum can be prefabricated from silicone rubber or is attached by applying a medically acceptable, self-curing silicone rubber compound.
  • the closed container with the drug carrier located therein is first sterilized in a conventional manner.
  • the active pharmaceutical ingredient which cannot be sterilized, is then introduced into the package through the septum under sterile caulks.
  • the desired layer thickness can be achieved by selecting the distance between the carrier and the container, which may still be expedient to limit the penetration of the liquid loaded with the non-sterilizable active ingredient onto a surface of the carrier by incorporating an edge into the containers.
  • the container as shown in Fig. 1 can be obtained by deep drawing in an appropriate form.
  • Corresponding glass containers can also be used. After inserting the drug carrier, the containers are closed with a semi-permeable membrane. The container can also be plugged or screwed together after inserting the drug carrier. After sterilization, the coating or loading, including the removal of water and / or solvent, is carried out via a semipermeable membrane. The solvent or water can also be drawn off via the septum by inserting a filter attachment. The drug carrier with the drug can then be removed by the user under sterile caulks by opening the container.
  • a carrier such as collagen is placed in the containers and sealed with a bacteria-proof membrane in the form of foils, such as Tyvek or special paper.
  • the number of containers with collagen required for the batches are sterilized using the established technology in the required wrappings, e.g. with ethylene oxide.
  • collagen is added via septum with the drug solution under sterile cauldrons loaded or coated.
  • the necessary precise dosing is ensured by using calibrated automatic dosing aids.
  • the moisture introduced must then be removed by means of freeze-drying in order to ensure that the applied plasma protein is anchored in the uppermost edge region of the drug carrier. In this process, the applied layer is literally "lyophilized".
  • the drug carrier is evenly charged with a drug such as gentamycin palmitate, appropriately dosed amounts of the drug in a suitable solvent such as chloroform are introduced via a septum, the drug carrier is soaked uniformly and the solvent is removed in a vacuum dryer with a solvent trap.
  • a suitable solvent such as chloroform
  • the final packaging can be carried out under sterile conditions.
  • vascular implants can be carried out according to the scheme shown in Fig. 2.
  • the containers shown can thus be used to biologize vascular prostheses with proteins such as collagen including the subsequent sterilization. These containers can also be used for the final packaging of the biologized implants.
  • Biologization of a knitted vascular prosthesis As shown schematically in Fig. 2, the knitted prosthesis is pulled over the tube and fixed to the notch with a thread. Then a ring made of flexible silicone material is pushed over the fixed vascular prosthesis at the designated position. A suitably sized, moistened dialysis tube is pulled over a tubular and vascular prosthesis and also fixed with a thread. The prosthesis can now be sterilized in the usual way with gamma radiation or ethylene oxide treatment or heat.
  • a 0.5% collagen solution can also be introduced via the septum, avoiding air bubbles between the tube and the semipermeable membrane, followed by freeze-drying and sterilization using ethylene oxide.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Hematology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Materials For Medical Uses (AREA)
  • Treatments Of Macromolecular Shaped Articles (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Packages (AREA)

Claims (3)

  1. Emballage avec un support de substance active placé à l' intérieur, chargé d'une substance active non stérilisable, caractérisé en ce qu'il est obtenu par les étapes de procédé suivantes :
    a) introduction du support de médicament dans une auge en matière synthétique,
    b) obturation de l'auge à l'aide d'une membrane semi-l perméable,
    c) stérilisation du récipient fermé,
    d) introduction de la substance active, sous forme dissoute ou en suspension, dans un solvant, au moyen d'un septum de l'auge ou de la membrane, et
    e) élimination du solvant en passant par la membrane semi-perméable.
  2. Procédé pour remplir des supports de médicaments renfermant un produit non stérilisable dans des cautèles stériles, le support de médicament chargé étant simultanément emballé dans des conditions stériles, caractérisé en ce que l'on
    a) introduit le support de médicament dans une auge en matière synthétique,
    b) obture l'auge à l'aide d'une membrane semi-perméable,
    c) stérilise le récipient fermé,
    d) introduit la substance active, sous forme dissoute ou en suspension, dans un savant, au moyen d'un septum de l'auge ou de la membrane, et
    e) élimine le solvant en passant par la membrane semi-perméable.
  3. Procédé selon la revendication 2, caractérisé en ce qu'à l'étape e), le solvant est éliminé par séchage par congélation ou par vaporisation sous une pression réduite, le cas échéant à température élevée.
EP87108011A 1986-07-02 1987-06-03 Emballage pour un applicateur de médicaments renfermant un produit non stérilisable et méthode de fabrication Expired - Lifetime EP0250904B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT87108011T ATE74772T1 (de) 1986-07-02 1987-06-03 Packung mit einem darin enthaltenen, mit einem nicht sterilisierbaren wirkstoff beladenen wirkstofftraeger und verfahren zu deren herstellung.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3622237 1986-07-02
DE19863622237 DE3622237A1 (de) 1986-07-02 1986-07-02 Packung mit einem darin enthaltenen, mit einem nicht sterilisierbaren wirkstoff beladenen wirkstofftraeger und verfahren zu deren herstellung

Publications (3)

Publication Number Publication Date
EP0250904A2 EP0250904A2 (fr) 1988-01-07
EP0250904A3 EP0250904A3 (en) 1989-03-15
EP0250904B1 true EP0250904B1 (fr) 1992-04-15

Family

ID=6304246

Family Applications (1)

Application Number Title Priority Date Filing Date
EP87108011A Expired - Lifetime EP0250904B1 (fr) 1986-07-02 1987-06-03 Emballage pour un applicateur de médicaments renfermant un produit non stérilisable et méthode de fabrication

Country Status (5)

Country Link
EP (1) EP0250904B1 (fr)
AT (1) ATE74772T1 (fr)
DE (2) DE3622237A1 (fr)
ES (1) ES2031470T3 (fr)
GR (1) GR3004381T3 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0600140A1 (fr) * 1992-12-04 1994-06-08 SULZER Medizinaltechnik AG Conditionnement pour une endoprothèse d'organe creux
US6976584B2 (en) * 2002-06-26 2005-12-20 Bausch & Lomb Incorporated Package for surgical implant
CN104224269A (zh) * 2013-06-14 2014-12-24 3M创新有限公司 止血包、止血按压组件和止血装置

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2952733A1 (de) * 1979-12-29 1981-07-02 Karl-Heinz Dr. 4802 Halle Sengewald Sterilisationsfaehige verpackung aus thermoplastischer kunststoffolie
NL8120305A (nl) * 1981-08-07 1983-05-02 Delmed Inc Werkwijzen voor de bereiding en toepassing van intraveneuze voedingssamenstellingen.
FR2543110B1 (fr) * 1983-03-21 1986-06-06 Vygon Sachet de conditionnement de produits steriles

Also Published As

Publication number Publication date
EP0250904A2 (fr) 1988-01-07
ES2031470T3 (es) 1992-12-16
DE3622237A1 (de) 1988-01-07
EP0250904A3 (en) 1989-03-15
DE3778218D1 (de) 1992-05-21
GR3004381T3 (fr) 1993-03-31
ATE74772T1 (de) 1992-05-15

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